Swissmedic has officially authorised VANFLYTA®, marking its initial regulatory approval. This announcement, dated September 30, 2025,…
Category: Europe
europe updates on medical device regulation and quality.
Critical Updates: Field Safety Notices Issued for Medical Devices (15–19 September 2025)
Healthcare professionals and regulatory teams, please take note. Between 15 and 19 September 2025, a range…
GHWP Announces Voluntary Withdrawal from IMDRF Membership
On June 24, 2025, the Global Harmonization Working Party (GHWP) officially withdrew as a member of…